For doctors

ADENURIC tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage.

ADENURIC works by reducing uric acid levels. Keeping uric acid levels low by taking ADENURIC once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.

If you are allergic (hypersensitive) to febuxostat, the active ingredient of ADENURIC, or any of the other ingredients in these tablets.

Take special care with ADENURIC

Tell your doctor before you start to take this medicine:

If you have or have had heart failure or heart problems

If you are being treated for high uric acid levels as a result of cancer disease or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)

If you have thyroid problems

If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.

For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment. It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.

Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).

Your doctor may ask you to have blood tests to check that your liver is working normally.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures:

Mercaptopurine (used to treat cancer)

Azathioprine (used to reduce immune response)

Theophylline (used to treat asthma)

Taking ADENURIC with food and drink

The tablets should be taken by mouth and can be taken with or without food.

Pregnancy and breast-feeding

It is not known if ADENURIC may harm your unborn child. Tell your doctor if you think you are pregnant or if you are planning to become pregnant as ADENURIC should not be used during pregnancy. It is not known if ADENURIC may pass into human breast milk. You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.

Driving and using machines

No studies on the effects of ADENURIC on the ability to drive and use machines have been performed. However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.

Important information about some of the ingredients of ADENURIC

ADENURIC tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.

Always take ADENURIC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

ADENURIC is available as either an 80 mg tablet or a 120 mg tablet. Your doctor will have prescribed the strength most suitable for you.

The usual dose is one tablet daily. The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.

The tablets should be taken by mouth and can be taken with or without food.

It is important that you do not stop taking ADENURIC unless your doctor tells you to.

Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.

If you take more ADENURIC than you should

In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.

If you forget to take ADENURIC

If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking ADENURIC

Do not stop taking ADENURIC without the advice of your doctor even if you feel better. If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Adenuric is used to treat long-term hyperuricaemia (high levels of uric acid or ‘urate’ in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as ‘gout’. Adenuric is used in patients who already have signs of a build-up of crystals, including arthritis (pain and inflammation in the joints) or tophi (‘stones’, larger deposits of urate crystals that can cause joint and bone damage).

The recommended dose of Adenuric is 80 mg once a day. This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks. Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric. Adenuric treatment should not be stopped if an attack of gout happens.

The active substance in Adenuric, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric acid levels low for long enough can also shrink tophi.

Adenuric has been studied in two main studies involving a total of 1,834 patients with hyperuricaemia and gout. The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia). The study lasted six months. The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.

In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg. The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/dl. Blood uric acid levels were measured every month.

Adenuric was more effective than allopurinol and placebo in reducing blood uric acid levels.

In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements. This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo. Similar results were seen in the second study after a year.

The most commonly reported side effects with Adenuric were abnormal liver test results, diarrhoea, nausea (feeling sick), headache and rash. Gout ‘flare-ups’ were often seen in the first weeks and months of treatment. There may also be an increased risk of some side effects affecting the heart and blood vessels, particularly in patients with a history of heart problems. For the full list of all side effects reported with Adenuric, see the package leaflet.

Adenuric should not be used in people who may be hypersensitive (allergic) to febuxostat or any of the other ingredients.

The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels, but that it could carry a greater risk of side effects affecting the heart and blood vessels. The Committee decided that Adenuric’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008. The marketing authorisation holder is Menarini International Operations Luxembourg S.A. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Adenuric, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.